NCT03881852

Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)

A Multi-center, Randomized, Double-blind, Placebo-controlled, 3-Week Crossover Study to Assess the Efficacy and Safety of AXS-12 in Subjects With Cataplexy and Excessive Daytime Sleepiness in Narcolepsy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) is a Phase 2, double-blind, randomized, placebo-controlled, crossover, multicenter trial of AXS-12 in patients with narcolepsy. Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks, or to AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks. Efficacy assessments will include the frequency of cataplexy attacks, and measures of other symptoms of narcolepsy.

Conditions

• Narcolepsy
• Cataplexy Narcolepsy
• Excessive Sleepiness

Interventions

Type	Name	Description
DRUG	AXS-12 (Reboxetine)	Dosed orally, twice daily for up to 3 weeks
DRUG	Placebo	Dosed orally, twice daily for up to 3 weeks

Timeline

• Start date: 2019-01-30
• Primary completion: 2019-11-27
• Completion: 2019-11-27
• First posted: 2019-03-20
• Last updated: 2023-08-24
• Results posted: 2023-08-24

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study